WSLCB - Work Group - Cannabinoid Science - Public Meeting
(August 3, 2023)

Here are some observations from the Thursday August 3rd Washington State Liquor and Cannabis Board Cannabinoid Science Work Group (WSLCB - Work Group - Cannabinoid Science) Public Meeting.

My top 4 takeaways:

• As work group members prepared to offer advice to aid regulator understanding of the cannabis plant, agency leadership recognized difficulty in keeping members involved in the effort.
  • The group last met on June 1st for a conversation about human safety guidance for different cannabis products, and also talked about developing a new standard for tetrahydrocannabinol (THC) detectability.
  • Research Manager Kathy Hoffman anticipated diminished turnout owing to a 2023 Cannabis Research Conference in Denver that day. She acknowledged that three of the original work group members had resigned and she’d be attempting to fill vacancies for the remaining meetings in 2023 (audio - 1m, Video - WSLCB, meeting minutes). Hoffman took roll call, revealing while a majority of members were present, almost half were absent (audio - 2m, Video - WSLCB).
    • Medicine Creek Analytics Science Director Amber Wise resigned after WSLCB Policy and Rules staff abruptly announced environmental pesticide actions without stakeholder input, though they subsequently changed course without more rulemaking or enforcement actions.
    • Hoffman didn’t call for either Gillian Schauer, Cannabis Regulators Association (CANNRA) Executive Director and UW tobacco and cannabis researcher, or Alicja Binkowska, a Polish researcher at the SWPS University in Warsaw who’d never attended a public meeting of the work group.
    • On August 29th, Hoffman described her plan to share her thoughts on the Denver conference during the October 11th Executive Management Team (EMT). 
    • On September 26th, she announced a new post starting October 15th with the Washington State Department of Labor and Industries (WA LNI).

• The first subgroup was looking into detectable levels of tetrahydrocannabinol (THC), which agency officials would need to more clearly specify in order to implement a law passed in the 2023 legislative session.
  • SB 5367 began as agency request legislation, but went on to be amended to require WSLCB to set a lowest “detectable level” of THC for cannabis products.
    • Implementation of SB 5367 in WSLCB Rulemaking began on June 21st, with staff indicating that stakeholder discussions focused on THC detectability were planned for October 16th and 18th. 
  • Hoffman reported that subgroup members held a closed meeting on July 12th to go over a proposal to "survey the private labs to talk about instrumentation” as a way to "separate theory from what is reliably possible” when it came to “the limits of technology, and help us…work towards safety standards.” The subgroup also considered designing “a matrix of product types,” she said. In attendance were (audio - 1m, Video - WSLCB):
    • Jessica Tonani  Verda Bio CEO 
    • Brad Douglass, Spoke Sciences Chief Regulatory Officer and Vice President of Chemistry
    • Richard Sams, KCA Laboratories Scientific Director
    • Holly Moody, Infinity Laboratories Senior Scientist and work group co-chair
    • Chris Beecher, ​​IROA Technologies Founder and Chief Scientific Officer,
    • Taylor Carter, University of South Carolina School of Medicine Columbia Postdoctoral Fellow and researcher 
  • Tonani offered that subgroup members recognized “different technology has different limits…we have a strong indication that most labs here in the state will probably” utilize high-performance liquid chromatography (HPLC) ultraviolet (UV)–visible spectroscopy equipment. She indicated that they’d looked at ASTM International papers on “theoretical standards” to “confirm our theory of what technology people are using, and then begin to divide out—based upon matrix and volume—what we actually believe may be detectable levels.” Tonani offered the example that “a larger volume beverage may have a different detectable level than a smaller edible just based upon the limitations of technology,” but the goal was consensus on “what we believe labs should be able to detect” (audio - 1m, Video - WSLCB).
  • Beecher spoke up to suggest there was still a “need to define what the need is before we define the equipment,” arguing “it would be a mistake to” limit “what you can see by limiting the technology.” He explained how “in chemistry and industrial levels, most of the pure materials that come in are tested and are characterized, and then the final products are characterized” (audio - 17m, Video - WSLCB).
    • Beecher felt “maybe the simplest way around it would be to suggest that you really need to test the material that is used in making the products separately, then the…products in a more complex matrix.” He believed products “in a more complex matrix…don't need the same level of scrutiny that the raw material does.” The concern Beecher had was “there are too many industrial accidents where” material “that's used in a product [was] contaminated.” He offered that “along these lines we test for pesticides…and I think the correct place to test for many of these things would be a more detailed test that probably occurred before the material was inserted into a product.” Beecher summarized that as a chemist, “I think virtually every product I buy [had] a cheat sheet on it that tells me…what it is and…what it's been tested for.” He stressed “we really need to figure out what we need to see and when we need to see it and, and that may not be a one-time look…that sees and does everything.”
    • Tonani referenced her time on the Washington State Hemp in Food Task Force, telling the group how this perspective had come up. She reported their sentiment was against testing cannabis material primarily because then "spot checking downstream" by testing finished products became less reliable at showing contaminated inputs. Moreover, with hemp consumables “maybe not all products would be manufactured in Washington,” she commented. Her recollection was “there were some concerns with other groups…on whether or not just testing midstream would be feasible.”
    • Beecher responded that “one of the restrictions to sell in the state would be that the material would have to be certified” as having been at least partially “made within the state and, and on some level it favors local producers so I would think that the State would find that somewhat attractive.” Hoffman described this approach as similar to the original cannabis testing process, but when pesticide testing rules were changed in March 2022 “we removed that first level” of testing to help ensure “product that hit the shelves for the consumer” could be tested, providing “a little more flexibility to producers and processors” as an approach to “mitigate cost…when we made pesticide testing mandatory.” Beecher considered it to be "faster, cheaper, and easier" to conduct batch certification of cannabis, then “you don't need to have as much rigor on the certification of the product…you're just verifying the concentrations are what you expect.”
    • “When I'm thinking back to the other work group,” Tonani said a concern “that came up was just essentially mixing and formulations” meant end product testing was more valuable. While she viewed stringent material testing as “definitely worth reevaluating but it was something that was debated pretty heavily in the last work group.” Understanding that there would be more numerous small batches for testing than with other commercial inputs, Beecher relayed that he had a "more industrial background" and was more experienced with larger material batches with greater "consistency and more reproducibility."
    • Tonani offered an example that reflected the concern over ending up with a “two-tiered testing system versus a single tiered testing system.” She regarded cannabis production as less consistent than manufacturing “Tree Top apple juice or something where you…test the upstream and then it's diluted downstream.” Tonani suggested they should review task force “notes on where that push back came from on not doing finished product testing.”
    • Beecher continued to debate the merits of having end testing focused on cannabinoid levels versus testing for other contaminants in raw materials: “I’m in North Carolina, where it is, not yet legal, and yet there are stores that are selling completely hallucinogenic products that are within the law,” he told the group, a situation he found “somewhat horrifying,” as hemp cannabidiol (CBD) extract could be chemically altered into other cannabinoids like THC. Tonani added this possibility meant a focus on end products allowed more oversight than testing cannabis plant material.
      • Find out more about Senate Bill 455, the 2022 North Carolina law legalizing hemp production and sale.
      • Beecher’s company, IROA Standards, sells internal standards and mass spectrometry libraries to laboratories, including cannabis standards for cannabis and potency analysis.
  • Hoffman moved on to the topic of HPLC-UV, asking Tonani to lay out the basics of the instrumentation. Tonani replied that “there's different technology people can use to detect cannabinoids,” and her understanding was that the overwhelming majority of accredited cannabis labs in Washington State used a HPLC-UV “platform.” She mentioned the technology allowed for “the gold standard that we've built our cannabinoid safety levels around.” While Tonanai was open to more formally surveying lab staff on what equipment they used, she favored a testing regime “based upon the gold standard technology that they're utilizing” (audio - 7m, Video - WSLCB).
    • Beecher shared how North Carolina regulators used mass spectrometry (MS) technology, asserting it was capable of “greater sensitivity and greater specificity. However, it is a much more expensive piece of equipment. There is no question about it.” He felt HPLC-UV was a “great piece of equipment, but I would guess that most of the UV bands for most of the cannabinoids are pretty similar.” Beecher’s impression was that North Carolina officials used MS “to get that higher level of detail.” He stated that HPLC-UV was “fine if you're…really verifying…that a product…doesn't contain twice as much as you think, but…I'm a mass spectroscopist myself, so I love mass spec.” Beecher argued that “pesticides [were] done on a mass spec…you don't have that much sensitivity in UV for the pesticides.”
    • Hoffman acknowledged the “other labs that will be testing and so we're going to have the Washington State Patrol (WSP) lab that will also be testing…and WSDA [Washington State Department of Agriculture] as well,” that should be involved in a survey.
    • Tonani put forward how it was "extremely important that we enable a system" for commercial companies to “get an answer that they can rely on.” She said that SB 5367 included a restriction barring any agency from purchasing liquid chromatography-mass spectrometry (LC-MS) technology specifically due to price concerns.
      • A WSP fiscal note incorporated staff analysis that should “evidentiary standards require the identification of THC concentrations consistent with new and current definitions…we will need to expand our concentration testing protocols.” They insisted “each of our three Controlled Substance Laboratories would need to acquire a [LC-MS] instrument…at an estimated cost of $600[,000],” but as this was prohibited by the law, WSP lab staff would “be unable to fully meet the new evidentiary standards created.”
        • An additional WSP toxicology lab in Federal Way was planned to open by 2024. 
      • WSLCB business opportunities had shown agency leaders entered into a “Contract with Orange Photonics, Inc. to provide Light Lab 3 Cannabis Analyzers,” in addition to a previous purchase of equipment from the company in November 2022.
    • WSLCB Director of Policy and External Affairs Justin Nordhorn highlighted that SB 5367 didn’t require HPLC instruments, but WSLCB officials did need to contemplate testing standard implications “for the private labs and the State labs.” He also wanted them to keep in mind “what is the best practice,” as well as ensuring regulators worked within “what the current statutory language says.”
  • Carter inquired if there was a state authority testing for “a spike sample across all these labs…a central agency to have one person with the set level of spike sample to test all of them.” Tonani mentioned a planned transfer of lab accreditation authority from WSLCB to the Washington State Department of Ecology (DOE) and speculated, “I think that there'll be a little bit more ring testing type protocols in the future” to monitor lab proficiency (audio - 2m, Video - WSLCB).
    • Beecher said the US Food and Drug Administration (US FDA) “sends out a sample on a regular basis…that they have certified and they send it to any lab that requests it,” finding it “might not be a bad idea to participate in the FDA program” as an accreditation criteria “to prove that you are in fact doing the job.” Tonani mentioned that another subgroup “meeting yesterday” had brought this up, but participants raised the question of “whether you use ASTM standards, the FDA standards… different standards in different matrixes.”
    • Since the work group meeting, there had been an effort by WSDA staff to draft legislation for 2024 to bring cannabis lab accreditation under their authority rather than DOE.

• A subgroup on cannabis product safety standards had begun looking at how to define and arrange categories in order to ensure testing addressed varying product concerns.
  • Hoffman offered the context that the work group “identified four or five different areas of interest that they wanted to explore this year” which aligned with WSLCB leadership interests. Subgroups had been formed to reflect the top two issues, “that's why they're a little bit different, but there are some similarities and that we're creating sort of these buckets…to sort our thinking out and help inform our recommendations and the options” agency leaders contemplated.
  • Hoffman detailed how the group met on July 20th, featuring Tonani, Douglass, Carter, and David Gang, Washington State UniversityCenter for Cannabis Policy, Research, and Outreach (WSU CCPRO) Director and WSU Institute of Biological Chemistry Professor. She commented that they’d talked about product types and their associated standards, plus “discussed consumption concerns versus environmental concerns as they relate to production” (audio - 3m, Video - WSLCB).
    • Hoffman indicated Douglass underscored the importance of WSLCB staff looking at “total exposure" and how “he talked about orders of magnitude in the difference that occurs back to the concentration of the contaminant that's in the product.”
    • Carter felt there was "very efficient" progress in that meeting. Tonani conveyed the sense that since cannabis extraction wasn’t the same, “there may be standards within the state that we allow certain forms of remediation” based on the type of product exposure, like inhaled versus ingested.
  • “For this particular group I did start creating the buckets,” Hoffman said, “and one thing that was…interesting to me as I started to unpack the discussion” was crafting “a product standard bucket, and a production standard bucket.” Defining those areas would be helpful, she told group members, as well as looking at existing rule in relation to “what our thinking is around product standards and production standards” (audio - 4m, Video - WSLCB).
    • Tonani and Carter readily agreed with Hoffman’s assessment. Carter hoped the conversations around research on “consumption route” would continue, where “standard levels need to be based on like a toxicology level,” with some routes of administration being “potentially more harm down the line than others.”

• Bringing the meeting to an early close, Research Manager Kathy Hoffman provided information on upcoming work group meetings and activities (audio - 2m, Video - WSLCB).
  • Considering their next meeting in October, Hoffman planned to have draft copies of the work group recommendations “that have built out some of these buckets that we've been discussing” which would be reviewed. Before then, she expected there would be “at least three more subgroup meetings,” and lauded the progress on “deliverables,” indicating “we do want to be able to support the work in determining detectable levels that several agencies are working on.”
    • On September 26th, Hoffman mentioned the potential for future work group meetings. Additionally, she remarked there would be an addendum to the overall work group report that would “have the results—hopefully—of the WSDA survey” of labs, as staff there were a “little behind…at this point based on some of the rulemaking that they've been doing.”
  • Thanking participants, Nordhorn appreciated their input, “particularly when we're looking at some of the national interest right now with the farm bill and…FDA is looking for feedback right now and so I think this is really a group that can inform some of those conversations as well to make sure…multiple states are moving in the right direction”  (audio - 1m, Video - WSLCB).
    • Learn more about how federal officials were looking at hemp consumable regulation from a July 27th United States House Committee on Oversight and Accountability Health Care and Financial Services Subcommittee hearing on FDA actions around hemp and CBD, or an August 8th webinar by the federally-funded Prevention Technology Transfer Center Network Coordinating Office (PTTC NCO) on “Cannabidiol (CBD): Potential Harms, Side Effects, and Unknowns.”
  • The work group was scheduled to next meet on Thursday October 5th. A draft copy of the report was published which focused “on providing implementation pathways to determine ‘detectable’ levels of THC…The subgroup critically reviewed, compared, and contrasted materials pertaining to cannabis product testing and production standards from several resources, including but not limited to the Association of Analytical Chemists (AOAC), the American Society for Testing and Materials (ASTM), and the United States Pharmacopeia Food Chemical Codex (USPFCC). The CSWG asserts that the relationship between the limit of quantification (LOQ) and limit of detection (LOD) is predictable, and relatable 3 to 1. Currently, only LOQ is described in rule” as an “LOQ of 1.0 mg/g or 0.1%. Therefore, the LOD corresponding to this regulatory requirement is 0.03%. This limit can be achieved by laboratories that use methods that have specifications equal to or better than those of the AOAC methods. The group discussed an understanding that most certified cannabis testing labs in Washington were testing to 0.3%, making this standard achievable…The group also discussed potential variances in detectable amounts of THC across product type and offer[ed] ranges of detection based on product type, along with suggestions and considerations for cannabis product safety.”